Ignite Creation Date:
2024-05-05 @ 11:31 PM
Last Modification Date:
2024-10-26 @ 10:35 AM
Study NCT ID:
NCT01355913
Status:
COMPLETED
Last Update Posted:
2020-02-21
First Post:
2011-05-17
Brief Title:
Screening and Genetic Monitoring of Patients With Myelodysplastic Syndromes MDS Under Different Treatment Modalities by Cytogenetic Analyses of Circulating CD34Cells
Sponsor:
Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH
Organization:
Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH
Study Overview
Official Title:
Screening and Genetic Monitoring of Patients With MDS Under Different Treatment Modalities by Cytogenetic Analyses of Circulating CD34Cells
Status:
COMPLETED
Status Verified Date:
2020-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In myelodysplastic syndromes MDS the knowledge about chromosomal aberrations is important for diagnosis pathogenesis prognosis and treatment Usually chromosomal anomalies in MDS patients are detected in bone marrow cells by chromosome banding analyses of metaphases Alternatively or additionally they can be diagnosed by Fluorescence-in-Situ-Hybridization FISH The investigators here present a novel method for cytogenetic monitoring of MDS patients from peripheral blood which is representative for the clone size in bone marrow cells The purpose of this prospective multicenter non-interventional diagnostic study is to detect and to follow chromosomal aberrations from peripheral blood closely to assess karyotype evolution to detect rare abnormalities and to correlate the molecular-cytogenetic results with peripheral blood counts bone marrow morphology and treatment modalities and responses
Detailed Description:
Chromosomal aberrations in myelodysplastic syndromes MDS play a major role in diagnostics pathogenesis prognosis and more recently in treatment allocations Chromosomal anomalies can be detected by conventional chromosome banding analyses of bone marrow metaphases and most of them are provable by Fluorescence in situ hybridization FISH of circulating CD34 progenitor cells from peripheral blood For this prospective multicenter non-interventional diagnostic study sequential FISH analyses are performed on immunomagnetically enriched circulating CD34 cells from peripheral blood as follows A super-panel with the probes D7CEP7 EGR1 CEP8 CEP XY D20 p53 IGHBCL2 TELAML1 RB1 MLL 1p361q25 CSF1R all Abbott probes is used for initial screening every 12 months during follow-up and in every case of suspected progression A smaller standard-panel with the probes EGR1 D7CEP7 CEP8 p53 D20 CEP XY TELAML1 - plus if necessary an informative probe of the superpanel- was performed for analyses at short intervals every 2 months in the 1st year and every 3 months during the 2nd and 3rd year Peripheral blood counts are documented once a month and full blood counts with the number of peripheral blasts are recommended at the time point of each FISH analysis Bone marrow biopsies are not part of the study but they are recommended to be performed every 6 to 12 months in the course of the disease If a bone marrow biopsy is performed conventional chromosome banding analyses on bone marrow metaphases and additionally FISH analyses of enriched CD34 bone marrow cells and non-enriched bone marrow cells are performed The results from peripheral blood are correlated with those of conventional banding and FISH analyses performed on bone marrow samples The aims of this study are to detect acqired chromosomal aberrations in MDS patients from peripheral blood to follow these anomalies by frequent analyses to detect rare aberrations and to observe karyotype evolution from peripheral blood
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None